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Résultats de la recherche - 21 results

EU Batch Release Procedure: Annual Report 2023- Batch Release of IVMPs

Keywords: Vaccine- Immunological veterinary medicinal product- Quality control- Batch release Health Topics:  Efficacité et sécurité des vaccins, médicaments et produits de santé- Qualité des laboratoires ...

Guideline VBRN: Best Practice Guide for Electronic Platforms

batch release electronic platform Immunological Veterinary Medicinal Products vaccine Abstract: Official Medicines Control Laboratories (OMCL s) for Immunological Veterinary Medicinal Products (IVMP s) ...

Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines

“Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) ...

Determination of vaccine bacterial endotoxins content by the rFC method

factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...

The vaccine Batch release procedure in Europe

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire ULB Pharmacien d'industrie, ULB, ULB pharmacie (2022) Keywords: batch release Europe OMCL ...

Proposal for 3R reporting for Official Control Authority Batch Release

Vaccine quality control Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de ...

Panel discussion official forum Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release ...

Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines

Virtual (2021) Keywords: 3R Vaccine Potency Abstract: Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines ...

Expertise activities: participation in licensing procedures for vaccines and plasma-derived products

Publication Type: Scientific poster, presentation or proceeding Authors: Koen Brusselmans Source: Quality control and batch release of vaccines and blood products in Europe, NA, Issue WIV-ISP, NA ...

The Quality Control of Plasma-Derived Medicinal Products

Publication Type: Scientific poster, presentation or proceeding Authors: O. Carabin; Geneviève Waeterloos Source: Quality control and batch release of vaccines and blood products in Europe, NA, ...

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